To compare the effect of drug Dexmedetomidine with a placebo on the blood pressure and heart rate in patients undergoing Laparoscopic gall bladder removal surgery

Phase 4

Not yet recruiting

• Conditions: Other specified symptoms and signsinvolving the circulatory and respiratory systems,

• Registration Number: CTRI/2020/06/026037
• Lead Sponsor: Dr Dikshita Goswami

Brief Summary

In the current era, laparoscopic cholecystectomy is considered the gold standard of treatment for cholelithiasis due to the benefits of better postoperative pain profiles, lesser surgical wound complications and reduced hospital stay.[1]  Anaesthetic manoeuvres like direct laryngoscopy, tracheal intubation and extubation cause sympathetic stimulation. Moreover, the creation of pneumoperitoneum leads to an increase in plasma norepinephrine, epinephrine levels and plasma renin activity[2].These changes lead to an increase in heart rate, blood pressure, systemic and pulmonary vascular resistance and reduced cardiac output[2]. The reverse Trendelenburg position required for the surgical procedure also leads to reduction in venous return thereby causing a further reduction in cardiac output[3].The haemodynamic changes predispose the myocardium to ischaemia which may be life threatening in vulnerable patients[2]. In the past, various drugs like opioid analgesics, benzodiazepines, beta blockers, calcium channel blockers have been used to attenuate this stress response. α2  adrenergic agonists are increasingly being used to reduce stress response  to anaesthesia and surgery for their analgesic, anxiolytic, sedative and sympatholytic properties[4,5]. Dexmedetomidine (an α2 agonist) is a commonly used drug which decreases sympathetic tone, arterial pressure and heart rate in a dose dependent manner and produces sedation without causing respiratory depression[3,4].

In this study, we intend to give intravenous infusion of Dexmedetomidine hydrochloride at the rate of 0.4 microgram per kilogram of body weight per hour in Sodium Chloride 0.9% starting from 10 minutes prior to induction of anaesthesia till the end of operation and compare it with intravenous infusion of Sodium Chloride 0.9% as placebo and observe the effects on haemodynamic stability following laryngoscopy and intubation, pneumoperitoneum and extubation. In this randomised controlled study, the null hypothesis that dexmedetomidine does not reduce heart rate and blood pressure in patients undergoing laparoscopic cholecystectomy would be investigated.

 REFERENCES:

1) 1)   Samel SA, Patil BM, Nigalye N. Effect of Low Dose Dexmedetomidine Infusion on Hemodynamics in Patients Undergoing Laparoscopic Cholecystectomy: A Prospective Observational Study. Journal of Contemporary Medical Research. 2017;4(10):2069-74.

2)  2)  Manne GR, Upadhyay MR, Swadia VN. Effects of low dose dexmedetomidine infusion on haemodynamic stress response, sedation and post-operative analgesia requirement in patients undergoing laparoscopic cholecystectomy. Indian journal of anaesthesia. 2014 Nov;58(6):726.

 3)  3)  Bhattacharjee DP, Nayek SK, Dawn S, Bandopadhyay G, Gupta K. Effects of dexmedetomidine on haemodynamics in patients undergoing laparoscopic cholecystectomy-A comparative study. Journal of Anaesthesiology Clinical Pharmacology. 2010 Jan 1;26(1):45.

 4)  4)  Rachit B, Nanda HS, Mahesh K. Evaluation of Dexmedetomidine-0.5 mu g/kg and 1 mu g/kg in Blunting the Responses to Laryngoscopy and Intubation. INTERNATIONAL JOURNAL OF SCIENTIFIC STUDY. 2016 Feb 1;3(11):147-53.

5)   5)Ghodki PS, Thombre SK, Sardesai SP, Harnagle KD. Dexmedetomidine as an anesthetic adjuvant in laparoscopic surgery: An observational study using entropy monitoring. Journal of anaesthesiology, clinical pharmacology. 2012 Jul;28(3):334.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-07-23

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Patients with valid consent 2) American Society of Anaesthesiologists Physical Status 1 or 2 3) Undergoing elective laparoscopic cholecystectomy requiring endotracheal intubation.

Exclusion Criteria

1. Patient refusal 2) Patients having known allergy either to Dexmedetomidine or any of the drugs to be administered 3) Patients with airway problems (anticipated/ unanticipated difficult airway) 4) Pregnant or lactating females 5) Patients with known history of substance abuse 6) Patients with hypotension, bradycardia or pre existing heart block.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the effect of Dexmedetomidine infusion on haemodynamic stability (Systolic and Diastolic Blood Pressure, Mean Arterial Pressure and Heart Rate) in response to the following events in patients undergoing laparoscopic cholecystectomy: laryngoscopy and endotracheal intubation, creation of pneumoperitoneum and extubation.	Before starting infusion, 10 minutes after starting infusion, 1 minute after laryngoscopy and intubation, after pneumoperitoneum at- 1 minute, 15 minutes, 30 minutes, 45 minutes, 60 minutes and 1 minute after extubation

Secondary Outcome Measures

Name	Time	Method
To observe the effects on level of sedation at the end of surgery	post operatively at 1 minute, 15 minutes, 30 minutes and 60 minutes after extubation
To oberve the effects on analgesia in immediate post operative period	post operatively at 1 minute, 15 minutes, 30 minutes and 60 minutes after extubation
To record other relevant observations, if any	From the start of infusion at 10 minutes prior to induction of anaesthesia till 60 minutes after extubation

Trial Locations

Locations (1)

Gauhati Medical College and Hospital; 🇮🇳 Kamrup, ASSAM, India

Gauhati Medical College and Hospital

🇮🇳Kamrup, ASSAM, India

Dr Dikshita Goswami

Principal investigator

7430953643

dkshtgoswami@gmail.com